Table 3.
Safety summary from the ALZ-801 (capsule, tablet) phase I multiple dose ascending study (i.e. Study 2 in Table 1)
| A. SAEs | |||
|---|---|---|---|
| Group | Subjects affected by SAE/exposed | No. of deaths (all causes) | No. of deaths resulting from AEs |
| Part 1: Cohort A, 171 and 256.5 mg ALZ-801 capsule, fasted | 0/9 | 0 | 0 |
| Part 1: Cohort B, 256.5 and 340 mg ALZ-801 capsule, fasted | 0/9 | 0 | 0 |
| Part 1: Cohort C, 256.5 and 340 mg ALZ-801 capsule, fed | 0/9 | 0 | 0 |
| Part 1: Combined placebo groups of three cohorts, fed/fasted | 0/9 | 0 | 0 |
| Part 2: Cohort D, 265 mg ALZ-801 tablet, fed | 0/9 | 0 | 0 |
| Part 2: Placebo group, fed | 0/3 | 0 | 0 |
| B. TEAEs | |||||
|---|---|---|---|---|---|
| TEAEs | Placebo | Cohort A 171 mg bid 256.5 mg qd Capsule, fasted |
Cohort B 256.5 mg bid 340 mg qd Capsule, fasted |
Cohort C 256.5 mg bid 340 mg bid Capsule, fed |
Cohort D 265 mg bid Tablet, fed |
| Nausea | |||||
| Week 1 | 1 (11.1) | 3 (33.3) | 4 (44.4) | 5 (55.6) | 3 (33.3) |
| Week 2 | 0 | 3 (33.3) | 0 | 0 | NA |
| Vomiting | |||||
| Week 1 | 0 | 0 | 2 (22.2) | 2 (22.2) | 1 (11.1) |
| Week 2 | 0 | 0 | 2 (22.2) | 0 | NA |
Data are expressed as cases (%)
The timeframe for reporting adverse events: from screening visit (day − 28 to day − 2) to follow-up visit 7–10 days after the last dose of study medication (Part 1: days 21–24; Part 2: days 14–17). Assessment type: systematic
NA not applicable, SAEs serious adverse events, TEAEs treatment-emergent adverse events, bid twice daily, qd once daily